BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 20925164 · Received December 13, 2024

    Report

    Report Number
    1911916-2024-00898
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    December 6, 2024
    Report Date
    January 14, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THERE WAS A WHITE SUBSTANCE ON ONE OF THE NEEDLES. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY, OUT OF THE PACKAGING BLISTER, AND AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4212669. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL # 305180 BATCH # 4212669 VERBATIM: NOT SURE IF YOU ARE THE CORRECT REP TO ASSIST WITH THIS OR NOT. ONE OF OUR CLINICS REPORTED A WHITE SUBSTANCE ON ONE OF THEIR NEEDLES AS THEY PULLED IT OUT OF THE PACKAGING. THEY PULLED 2 OTHERS THAT THEY COULD SEE THAT ALSO WAS AFFECTED. CAN YOU PLEASE REPORT THIS AND INVESTIGATE? PICTURE BELOW WITH PART AND LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407533 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4212669 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown